System and method for monitoring air flow from a person

ABSTRACT

Monitoring airflow from a person is accomplished by using a central server arranged to receive and communicate data together with at least one microprocessor-based subsystem. The subsystem includes a microprocessor, a display and a memory. It presents information to the person on the display and processes a digital signal representing airflow from the person. Airflow-related data is communicated to the central server and, in turn, is communicated to at least one health care professional computer. The system can be used to realize systems for self-care monitoring and control of afflictions and physical conditions, such as chronic respiratory afflictions. The system can also be used together with other monitoring devices, such as glucose, blood pressure, pulse and temperature monitors, to monitor the person&#39;s conition and to communicate related data to the central server.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of application Ser. No. 09/237,194,filed on Jan. 26, 1999, which is a Continuation of application Ser. No.08/481,925, filed on Jun. 7, 1995, now U.S. Pat. No. 5,899,855, issuedMay 4, 1999, which is a FWC of application Ser. No. 08/233,397, filed onApr. 26, 1994, now abandoned, which is a Continuation of applicationSer. No. 07/977,323, filed on Nov. 11, 1992, now U.S. Pat. No.5,307,263, issued on Apr. 26, 1994. This application is also related toU.S. Pat. No. 6,168,563 which is a Continuation-In-Part of theabove-referenced U.S. Pat. No. 5,899,855, and a Continuation-In-Part ofU.S. Pat. No. 5,997,476, which claims the priority to ProvisionalApplication Ser. No. 60/041,746, filed Mar. 28, 1997 and ProvisionalApplication Ser. No. 60/041,751, filed Mar. 28, 1997. This applicationis also related to U.S. Pat. No. 5,897,493, which also claims priorityto Provisional Application No. 60/041,751 and 60/041,746 both filed Mar.28, 1997. This application is also related to application Ser. No.10/233,296, filed on Aug. 30, 2002; application Ser. No. 09/665,242,filed on Mar. 28, 1997; application Ser. No. 10/319,427, filed Dec. 12,2002, and application Ser. No. 09/713, 922, filed on Nov. 15, 2000.

BACKGROUND OF INVENTION

Controlling or curing conditions of ill health generally involves bothestablishing a therapeutic program and monitoring the progress of theafflicted person. Based on that progress, decisions can be made as toaltering therapy to achieve a cure or maintain the affliction orcondition at a controlled level. Successfully treating certain healthconditions calls for rather frequent monitoring and a relatively highdegree of patient participation. For example, in order to establish andmaintain a regimen for successful diabetes care, a diabetic shouldmonitor his or her blood glucose level and record that information alongwith the date and time at which the monitoring took place. Since diet,exercise, and medication all affect blood glucose levels, a diabeticoften must record data relating to those items of information along withblood glucose level so that the diabetic may more closely monitor his orher condition and, in addition, can provide information of value to thehealthcare provider in determining both progress of the patient anddetecting any need to change the patient's therapy program.

Advances in the field of electronics over the past several years havebrought about significant changes in medical diagnostic and monitoringequipment, including arrangements for self-care monitoring of variouschronic conditions. With respect to the control and monitoring ofdiabetes, relatively inexpensive and relatively easy-to-use bloodglucose monitoring systems have become available that provide reliableinformation that allows a diabetic and his or her healthcareprofessional to establish, monitor and adjust a treatment plan (diet,exercise, and medication). More specifically, microprocessor-based bloodglucose monitoring systems are being marketed which sense the glucoselevel of a blood sample that is applied to a reagent-impregnated regionof a test strip that is inserted in the glucose monitor. When themonitoring sequence is complete, the blood glucose level is displayedby, for example, a liquid crystal display (LCD) unit.

Typically, currently available self-care blood glucose monitoring unitsinclude a calendar/clock circuit and a memory circuit that allows anumber of blood glucose test results to be stored along with the dateand time at which the monitoring occurred. The stored test results(blood glucose level and associated time and date) can be sequentiallyrecalled for review by the blood glucose monitor user or a healthprofessional by sequentially actuating a push button or other controlprovided on the monitor. In some commercially available devices, theaverage of the blood glucose results that are stored in the monitor (orthe average of the results for a predetermined period of time, e.g.,fourteen days) also is displayed during the recall sequence. Further,some self-care blood glucose monitors allow the user to tag the testresult with an “event code” that can be used to organize the testresults into categories. For example, a user might use a specific eventcode to identify test results obtained at particular times of the day, adifferent event code to identify a blood glucose reading obtained aftera period of exercise, two additional event codes to identify bloodglucose readings taken during hypoglycemia symptoms and hyperglycemiasymptoms, etc. When event codes are provided and used, the event codetypically is displayed with each recalled blood glucose test result.

Microprocessor-based blood glucose monitoring systems have advantagesother than the capability of obtaining reliable blood glucose testresults and storing a number of the results for later recall and review.By using low power microprocessor and memory circuits and powering theunits with small, high capacity batteries (e.g., a single alkalinebattery), extremely compact and light designs have been achieved thatallow taking the blood glucose monitoring system to work, school, oranywhere else the user might go with people encountered by the user notbecoming aware of the monitoring system. In addition, mostmicroprocessor-based self-care blood glucose monitoring systems have amemory capacity that allows the system to be programmed by themanufacturer so that the monitor displays a sequence of instructionsduring any necessary calibration or system tests and during the bloodglucose test sequence itself. In addition, the system monitors varioussystem conditions during a blood glucose test (e.g., whether a teststrip is properly inserted in the monitor and whether a sufficientamount of blood has been applied to the reagent impregnated portion ofthe strip) and if an error is detected generates an appropriate display(e.g., “retest”). A data port may be provided that allows test resultsstored in the memory of the microprocessor-based blood glucosemonitoring system to be transferred to a data port (e.g., RS-232connection) of a personal computer or other such device for subsequentanalysis.

Microprocessor-based blood glucose monitoring systems are a significantadvance over previously available self-care systems such as thoserequiring a diabetic to apply a blood sample to reagent activatedportions of a test strip; wipe the blood sample from the test stripafter a predetermined period of time; and, after a second predeterminedperiod of time, determine blood glucose level by comparing the color ofthe reagent activated regions of the test strip with a color chartsupplied by the test strip manufacturer. Despite what has been achieved,numerous drawbacks and disadvantages still exist. For example,establishing and maintaining diabetic healthcare often requires thediabetic to record additional data pertaining to medication, foodintake, and exercise. However, the event codes of currently availablemicroprocessor blood glucose monitoring systems provide only limitedcapability for tagging and tracking blood glucose test results accordingto food intake and other relevant factors. For example, the event codesof currently available monitoring systems only allow the user toclassify stored blood glucose readings in a manner that indicates bloodglucose tests taken immediately after a heavy, light or normal meal.This method of recording information not only requires subjectivejudgment by the system user, but will not suffice in a situation inwhich successfully controlling the user's diabetes requires therecording and tracking of relatively accurate information relating tofood intake, exercise, or medication (e.g., insulin dosage). Anotherwise significant advantage of currently available blood glucosemonitoring systems is lost when blood glucose test results must berecorded and tracked with quantitative information relating tomedication, food intake, or exercise. Specifically, the system user mustrecord the required information along with a time and date tagged bloodglucose test result by, for example, writing the information in a logbook.

The use of event codes to establish subcategories of blood glucose testresults has an additional disadvantage or drawback. In particular,although alphanumeric display devices are typically used in currentlyavailable microprocessor-based blood glucose monitoring systems, thedisplay units are limited to a single line of information having on theorder of six characters. Moreover, since the systems include noprovision for the user to enter alphanumeric information, any eventcodes that are used must be indicated on the display in a genericmanner, e.g., displayed as “EVENT 1”, EVENT 2” etc. This limitationmakes the system more difficult to use because the diabetic must eithermemorize his or her assignment of event codes or maintain a list thatdefines the event codes. The limited amount of data that can bedisplayed at any one time presents additional drawbacks anddisadvantages. First, instructions and diagnostics that are displayed tothe user when calibrating the system and using the system to obtain ablood glucose reading must be displayed a line at a time and in manycases, the information must be displayed in a cryptic manner.

The above-discussed display limitations and other aspects of currentlyavailable blood glucose monitoring systems is disadvantageous in yetanother way. Little statistical information can be made available to theuser. For example, in diabetic healthcare maintenance, changes orfluctuations that occur in blood glucose levels during a day, a week, orlonger period can provide valuable information to a diabetic and/or hisor her healthcare professional. As previously mentioned, currentlyavailable systems do not allow associating blood glucose test resultswith attendant quantitative information relating to medication, foodintake, or other factors such as exercise that affect a person's bloodglucose level at any particular point in time. Thus, currently availableblood glucose monitoring systems have little or no capability for thegenerating and display of trend information that may be of significantvalue to a diabetic or the diabetic's healthcare professional.

Some currently available blood glucose monitoring systems provide a dataport that can be interconnected with and transfer data to a personalcomputer (e.g., via an RS-232 connection). With such a system and asuitable programmed computer, the user can generate and display trendinformation or other data that may be useful in administering his or hertreatment plan. Moreover, in such systems, data also can be transferredfrom the blood glucose monitoring system to a healthcare professional'scomputer either directly or remotely by telephone if both the bloodglucose monitoring system (or computer) to which the data has beendownloaded and the healthcare professional's computer are equipped withmodems. Although such a data transfer provision allows a healthcareprofessional to analyze blood glucose data collected by a diabetic, thisaspect of currently available blood glucose monitoring systems has notfound widespread application. First, the downloading and subsequentanalysis feature can only be used by system users that have ready accessto a computer that is programmed with appropriate software and, inaddition, have both the knowledge required to use the software (and theinclination to do so). This same problem exists with respect to datatransfer to (and subsequent analysis by) a healthcare professional.Moreover, various manufacturers of systems that currently provide a datatransfer feature do not use the same data format. Therefore, if ahealthcare professional wishes to analyze data supplied by a number ofdifferent blood glucose monitoring systems, he or she must possesssoftware for each of the systems and must learn to conduct the desiredanalyses with each software system.

The above-discussed disadvantages and drawbacks of microprocessor-basedself-care health monitoring systems take on even greater significancewith respect to children afflicted with diabetes, asthma and otherchronic illnesses. In particular, a child's need for medication andother therapy changes as the child grows. Current microprocessor-basedself-care health monitoring systems generally do not provide informationthat is timely and complete enough for a healthcare professional torecognize and avert problems before relatively severe symptoms develop.Too often, a need for a change in medication and/or other changes intherapeutic regimen is not detected until the child's condition worsensto the point that emergency room care is required.

Further, currently available microprocessor-based health monitoringsystems have not been designed with children in mind. As previouslymentioned, such devices are not configured for sufficient ease of use insituations in which it is desirable or necessary to record and trackquantitative information that affects the physical condition of thesystem user (e.g., medication dosage administered by a diabetic and foodintake). Children above the age at which they are generally capable ofobtaining blood samples and administering insulin or other medicationgenerally can learn to use at least the basic blood glucose monitoringfeatures of currently available microprocessor-based blood glucosemonitoring systems. However, the currently available monitoring systemsprovide nothing in the way of motivation for a child to use the deviceand, in addition, include little or nothing that educates the childabout his or her condition or treatment progress.

The lack of provision for the entering of alphanumeric data also can bea disadvantage. For example, currently available blood glucosemonitoring systems do not allow the user or the healthcare professionalto enter information into the system such as medication dosage and otherinstructions or data that is relevant to the user's self-care healthprogram.

The above-discussed disadvantages and drawbacks of currently availablemicroprocessor-based blood glucose monitoring systems also have beenimpediments to adopting the basic technology of the system for otherhealthcare situations in which establishing and maintaining an effectiveregimen for cure or control is dependent upon (or at least facilitatedby) periodically monitoring a condition and recording that conditionalong with time and date tags and other information necessary or helpfulin establishing and maintaining a healthcare program.

SUMMARY OF INVENTION

This invention provides a new and useful system for healthcaremaintenance in which the invention either serves as a peripheral deviceto (or incorporates) a small handheld microprocessor-based unit of thetype that includes a display screen, buttons or keys that allow a userto control the operation of the device and a program cartridge or otherarrangement that can be inserted in the device to adapt the device to aparticular application or function. The invention in effect converts thehandheld microprocessor device into a healthcare monitoring system thathas significant advantages over systems such as the currently availableblood glucose monitoring systems. To perform this conversion, theinvention includes a microprocessor-based healthcare data managementunit, a program cartridge and a monitoring unit. When inserted in thehandheld microprocessor unit, the program cartridge provides thesoftware necessary (program instructions) to program the handheldmicroprocessor unit for operation with the microprocessor-based datamanagement unit. Signal communication between the data management unitand the handheld microprocessor unit is established by an interfacecable. A second interface cable can be used to establish signalcommunication between the data management unit and the monitoring unitor, alternatively, the monitoring unit can be constructed as a plug-inunit having an electrical connector that mates with a connector mountedwithin a region that is configured for receiving the monitoring unit.

In operation, the control buttons or keys of the handheldmicroprocessor-based unit are used to select the operating mode for boththe data management unit and the handheld microprocessor-based unit. Inresponse to signals generated by the control buttons or keys, the datamanagement unit generates signals that are coupled to the handheldmicroprocessor unit and, under control of the program instructionscontained in the program cartridge, establish an appropriate screendisplay on the handheld microprocessor-based unit display. In selectingsystem operating mode and other operations, the control buttons are usedto position a cursor or other indicator in a manner that allows thesystem user to easily select a desired operating mode or function andprovide any other required operator input. In the disclosed detailedembodiment of the invention several modes of operation are madeavailable.

In the currently preferred embodiments of the invention, the handheldmicroprocessor unit is a compact video game system such as the systemmanufactured by Nintendo of America Inc. under the trademark “GAME BOY.”Use of a compact video game system has several general advantages,including the widespread availability and low cost of such systems.Further, such systems include switch arrangements that are easilyadapted for use in the invention and the display units of such systemsare of a size and resolution that can advantageously be employed in thepractice of the invention. In addition, such systems allow educationalor motivational material to be displayed to the system user, with thematerial being included in the program cartridge that provides themonitor system software or, alternatively, in a separate programcartridge.

The use of a compact video game system for the handheldmicroprocessor-based unit of the invention is especially advantageouswith respect to children. Specifically, the compact video game systemsof the type that can be employed in the practice of the invention arewell known and well accepted by children. Such devices are easilyoperated by a child and most children are well accustomed to using thedevices in the context of playing video games. Motivational andeducational material relating to the use of the invention can bepresented in game-like or animated format to further enhance acceptanceand use of the invention by children that require self-care healthmonitoring.

A microprocessor-based health monitoring system that is configured inaccordance with the invention provides additional advantages for boththe user and a healthcare professional. In accordance with one aspect ofthe invention, standardized reports are provided to a physician or otherhealthcare provider by means of facsimile transmission. To accomplishthis, the data management unit of the currently preferred embodiments ofthe invention include a modem which allows test results and other datastored in system memory to be transmitted to a remote clearinghouse viaa telephone connection. Data processing arrangements included in theclearinghouse perform any required additional data processing; formatthe standardized reports; and, transmit the reports to the facsimilemachine of the appropriate healthcare professional.

The clearinghouse also can fill an additional communication need,allowing information such as changes in medication dosage or otherinformation such as modification in the user's monitoring schedule to beelectronically sent to a system user. In arrangements that incorporatethis particular aspect of the invention, information can be sent to theuser via a telephone connection and the data management unit modem whena specific inquiry is initiated by the user, or when the userestablishes a telephone connection with the clearinghouse for otherpurposes such as providing data for standardized reports.

The clearinghouse-facsimile aspect of the invention is important becauseit allows a healthcare professional to receive timely information aboutpatient condition and progress without requiring a visit by the patient(system user) and without requiring analysis or processing of test databy the healthcare professional. In this regard, the healthcareprofessional need not possess or even know how to use a computer and/orthe software conventionally employed for analysis of blood glucose andother health monitoring data and information.

The invention also includes provision for data analysis and memorystorage of information provided by the user and/or the healthcareprofessional. In particular, the data management units of the currentlypreferred embodiments of the invention include a data port such as anRS-232 connection that allows the system user or healthcare professionalto establish signal communication between the data management unit and apersonal computer or other data processing arrangement. Blood glucosetest data or other information can then be downloaded for analysis andrecord keeping purposes. Alternatively, information such as changes inthe user's treatment and monitoring regimen can be entered into systemmemory. Moreover, if desired, remote communication between the datamanagement unit and the healthcare professional's computer can beestablished using the clearinghouse as an element of the communicationslink. That is, in the currently preferred arrangements of the inventiona healthcare professional has the option of using a personal computerthat communicates with the clearinghouse via a modem and telephone linefor purposes of transmitting instructions and information to a selecteduser of the system and/or obtaining user test data and information forsubsequent analysis.

The invention can be embodied in forms other than those described above.For example, although small handheld microprocessor units such as ahandheld video game system or handheld microprocessor units of the typeoften referred to as “palm-computers provide many advantages, there aresituations in which other compact microprocessor units canadvantageously be used. Among the various types of units that can beemployed are using compact video game systems of the type that employ aprogram cartridge, but uses a television set or video monitor instead ofa display unit that is integrated into the previously described handheldmicroprocessor units.

Those skilled in the art also will recognize that the above-describedmicroprocessor-implemented functions and operations can be apportionedbetween one or more microprocessors in a manner that differs from theabove-described arrangement. For example, in some situations, theprogrammable microprocessor unit and the program cartridge used inpracticing the invention may provide memory and signal processingcapability that is sufficient for practicing the invention. In suchsituations, the microprocessor of the microprocessor-based datamanagement unit of the above embodiments in effect is moved into thevideo game system, palm-computer or programmable microprocessor device.In such an arrangement, the data management unit can be realized as arelatively simple interface unit that includes little or no signalprocessing capability. Depending upon the situation at hand, theinterface unit may or may not include a telephone modem and/or an RS-232connection (or other data port) for interconnecting the healthcaresystem with a computer or other equipment. In other situations, thefunctions and operations associated with processing of the monitoredhealth care data may be performed by a microprocessor that is added toor already present in the monitoring device that is used to monitorblood glucose or other condition.

Because the invention can be embodied to establish systems havingdifferent levels of complexity, the invention satisfies a wide range ofself-care health monitoring applications. The arrangements that includea modem (or other signal transmission facility) and sufficient signalprocessing capability can be employed in situations in which reports areelectronically transmitted to a healthcare professional either in hardcopy (facsimile) form or in a signal format that can be received by andstored in the healthcare professional's computer. On the other hand,less complex (and, hence, less costly) embodiments of the invention areavailable for use in which transfer of system information need not bemade by means of telephonic data transfer or other remote transmissionmethods. In these less complex embodiments, transfer of data to ahealthcare professional can still be accomplished. Specifically, if theprogram cartridge includes a battery and suitable program instructions,monitored healthcare data can be stored in the program cartridge duringuse of the system as a healthcare monitor. The data cartridge can thenbe provided to the healthcare professional and inserted in aprogrammable microprocessor-based unit that is the same as or similar tothat which was used in the healthcare monitoring system. The healthcareprofessional can then review the data, and record it for later use,and/or can use the data in performing various analyses. If desired, themicroprocessor-based unit used by the healthcare professional can beprogrammed and arranged to allow information to be stored in thecartridge for return to and retrieval by the user of the healthcaremonitoring system. The stored information can include messages (e.g.,instructions for changes in medication dosage) and/or programinstructions for reconfiguring the program included in the cartridge soas to effect changes in the treatment regimen, the analyses or reportsto be generated by the healthcare monitoring system, or less importantaspects such as graphical presentation presented during the operation ofthe healthcare system.

BRIEF DESCRIPTION OF DRAWINGS

The foregoing aspects and many of the attendant advantages of thisinvention will become more readily appreciated as the same becomesbetter understood by reference to the following detailed description,when taken in conjunction with the accompanying drawings, wherein:

FIG. 1 is a block diagram that illustrates a healthcare monitoringsystem arranged in accordance with the invention;

FIG. 2 diagrammatically illustrates monitoring systems constructed inaccordance with the invention connected in signal communication with aremotely located computing facility which includes provision for makingthe data supplied by the monitoring system of the invention available toa designated healthcare professional and/or for providing data andinstructions to the system user;

FIG. 3 is a block diagram diagrammatically depicting the structuralarrangement of the system data management unit and its interconnectionwith other components of the system shown in FIG. 1.

FIGS. 4-10 depict typical system screen displays of data and informationthat can be provided by the arrangements shown in FIGS. 1-3; and

FIG. 11 diagrammatically illustrates an alternative healthcaremonitoring system that is arranged in accordance with the invention.

DETAILED DESCRIPTION

FIG. 1 depicts a self-care health monitoring system arranged inaccordance with the invention. In the arrangement shown in FIG. 1 a datamanagement unit 10 is electrically interconnected with a handheldmicroprocessor-based unit 12 via a cable 14. In the depictedarrangement, data management unit 10 also is electrically interconnectedwith a blood glucose monitor 16 of the type capable of sensing bloodglucose level and producing an electrical signal representative thereof.Although FIG. 1 illustrates blood glucose monitor 16 as being connectedto data management unit 10 by a cable 18, it may be preferable toconstruct blood glucose monitor 16 as a plug-in unit that is placed in arecess or other suitable opening or slot in data management unit 10.Regardless of the manner in which blood glucose monitor 16 isinterconnected with data management unit 10, both that interconnectionand cable 14 are configured for serial data communication between theinterconnected devices.

Also shown in FIG. 1 are two additional monitoring devices 20 and 22,which are electrically connected for serial data communication with datamanagement unit 10 via cables 24 and 26, respectively. Monitoring units20 and 22 of FIG. 1 represent devices other than blood glucose monitor16 that can be used to configure the invention for self-care healthmonitoring applications other than (or in addition to) diabetes care.For example, as is indicated in FIG. 1 the monitoring device 20 can be apeak-flow meter that provides a digital signal representative of theairflow that results when a person suffering from asthma or anotherchronic respiratory affliction expels a breath of air through the meter.As is indicated by monitor 22 of FIG. 1 various other devices can beprovided for monitoring conditions such as blood pressure, pulse, andbody temperature to thereby realize systems for self-care monitoring andcontrol of conditions such as hypertension, certain heart conditions andvarious other afflictions and physical conditions. Upon understandingthe hereinafter discussed aspects and features of the invention it willbe recognized that the invention is easily implemented for these andother types of healthcare monitoring. In particular, monitors used inthe practice of the invention can be arranged in a variety of ways aslong as the data to be recorded or otherwise employed by handheldmicroprocessor unit and/or data management unit 10 is provided in serialformat in synchronization with clock signals provided by data managementunit 10. As is the case with blood glucose monitor 16, the additionalmonitors can be configured as plug-in units that are directly receivedby data management unit 10, or can be connected to data management unit10 with cables (as shown in FIG. 1).

As is shown in FIG. 1, handheld microprocessor unit 12 includes adisplay screen 28 and a plurality of switches or keys (30, 32, 34, 36,and 38 in FIG. 1) which are mounted on a housing 40. Located in theinterior of housing 40, but not shown in FIG. 1 are a microprocessor,memory circuits, and circuitry that interfaces switches 30, 32, 34, 36,and 38 with the microprocessor. Stored in the memory of program handheldmicroprocessor unit 12 is a set of program instructions that establishesa data protocol that allows handheld microprocessor unit 12 to performdigital data signal processing and generate desired data or graphics fordisplay on display unit 28 when a program cartridge 42 is inserted in aslot or other receptacle in housing 40. That is, program cartridge 42 ofFIG. 1 includes read-only memory units (or other memory means such asbattery-powered random access memory) which store program instructionsand data that adapt handheld microprocessor 12 for operation in a bloodglucose monitoring system. More specifically, when the instructions anddata of program cartridge 42 are combined with program instructions anddata included in the internal memory circuits of handheld microprocessorunit 12 handheld microprocessor unit 12 is programmed for processing anddisplaying blood glucose information in the manner described below andadditional monitors 22 to provide health monitoring for asthma andvarious other previously mentioned chronic conditions. In each case, theplurality of switches or keys (30, 32, 34, 36 and 38 in FIG. 1) areselectively operated to provide signals that result in pictorial and/oralphanumeric information being displayed by display unit 42.

Various devices are known that meet the above-set forth description ofhandheld microprocessor unit 12. For example, compact devices areavailable in which the plurality of keys allows alphanumeric entry andinternal memory is provided for storing information such as names,addresses, phone numbers, and an appointment calendar. Small programcartridges or cards can be inserted in these devices to program thedevice for various purposes such as the playing of games, spreadsheetapplication, and foreign language translation sufficient for use intravel. More recently, less compact products that have more extensivecomputational capability and are generally called “palm top computers”have been introduced into the marketplace. These devices also caninclude provision for programming the device by means of an insertableprogram card or cartridge.

The currently preferred embodiments of the invention are configured andarranged to operate in conjunction with yet another type of handheldmicroprocessor unit. Specifically, in the currently preferredembodiments of the invention, program cartridge 42 is electrically andphysically compatible with commercially available compact video gamesystems, such as the system manufactured by Nintendo of America Inc.under the trademark “GAME BOY.” Configuring data management unit 10 andprogram cartridge 42 for operation with a handheld video game system hasseveral advantages. For example, the display unit of such a deviceprovides display resolution that allows the invention to display bothmulti-line alphanumeric information and graphical data. In this regard,the 160×144 pixel dot matrix-type liquid crystal display screencurrently used in the above-referenced compact video game systemsprovides sufficient resolution for at least six lines of alphanumerictext, as well as allowing graphical representation of statistical datasuch as graphical representation of blood glucose test results for aday, a week, or longer.

Another advantage of realizing handheld microprocessor unit 12 in theform of a compact video game system is the relatively simple, yetversatile arrangement of switches that is provided by such a device. Forexample, as is indicated in FIG. 1 a compact video game system includesa control pad that allows an object displayed on display unit 42 to bemoved in a selected direction (i.e., up-down or left-right). As also isindicated in FIG. 1, compact video game systems typically provide twopair of distinctly-shaped push button switches. In the arrangement shownin FIG. 1, a pair of spaced-apart circular push button switches (36 and38) and a pair of elongate switches (32 and 34) are provided. Thefunctions performed by the two pairs of switches is dependent upon theprogram instructions contained in each program cartridge 42.

Yet another advantage of utilizing a compact video game system forhandheld microprocessor-based unit 12 of FIG. 1 is the widespreadpopularity and low cost of such units. In this regard, manufacture andsale of a data management unit blood glucose monitor 16 and programcartridge 42 that operate in conjunction with a compactmicroprocessor-based video allows the self-care health monitoring systemof FIG. 1 to be manufactured and sold at a lower cost than could berealized in an arrangement in which handheld unit 12 is designed andmanufactured solely for use in the system of FIG. 1.

An even further advantage of using a compact video game system forhandheld microprocessor 12 is that such video game systems include meansfor easily establishing the electrical interconnection provided by cable14 in FIG. 1. In particular, such compact video game systems include aconnector mounted to the game unit housing (40 in FIG. 1) and a cablethat can be connected between the connectors of two video game units toallow interactive operation of the two interconnected units (i.e., toallow contemporaneous game play by two players or competition betweenplayers as they individually play identical but separate games). In thepreferred embodiments of the invention, the “two-player” cable suppliedwith the compact video game unit being used as handheld microprocessorunit 12 is used as cable 14 to establish serial data communicationbetween the handheld microprocessor unit 12 (compact video game system)and data management unit 10. In these preferred embodiments, the programinstructions stored on the memory of data management unit 10 and programcartridge 42 respectively program data management unit 10 and thecompact video game system (i.e., handheld microprocessor unit 12) forinteractive operation in which switches 30, 32, 34, 36 and 38 are usedto control the operation of data management unit 10 (e.g., to select aparticular operational mode such as performance of a blood glucose testor the display of statistical test data and, in addition, to controloperation such as selection of an option during operation of the systemin a particular operational mode). In each operational mode, datamanagement unit 10 processes data in accordance with programinstructions stored in the memory circuits of data management unit 10.Depending upon the operational mode selected by the user, data issupplied to data management unit 10 by blood glucose monitor 16 byadditional monitors (20 and 22 in FIG. 1) or any interconnectedcomputers or data processing facility (such as the hereinafter describeduser's computer 48 and clearinghouse 54 of FIG. 1) During suchoperation, mode switches 30, 32, 34, 36 and 38 are selectively activatedso that signals are selectively coupled to the video game system(handheld microprocessor unit 12) and processed in accordance withprogram instructions stored in program cartridge 42. The signalprocessing performed by handheld microprocessor unit 12 results in thedisplay of alphanumeric, symbolic, or graphic information on the videogame display screen (i.e., display unit 28 in FIG. 1) which allow theuser to control system operation and obtain desired test results andother information.

Although the above-discussed advantages apply to use of the invention byall age groups, employing a compact video game system in the practice ofthe invention is of special significance in monitoring a child's bloodglucose or other health parameters. Children and young adults arefamiliar with compact video game systems. Thus, children will accept ahealth monitoring system incorporating a compact video game system morereadily than a traditional system, even an embodiment of the inventionthat uses a different type of handheld microprocessor unit. Moreover, anembodiment of the invention that functions in conjunction with a compactvideo game system can be arranged to motivate children to monitorthemselves more closely than they might otherwise by incorporatinggame-like features and/or animation in system instruction and testresult displays. Similarly, the program instructions can be included inprogram cartridges 41, 42 and 43 (or additional cartridges) that allowchildren to select game-like displays that help educate the child abouthis or her condition and the need for monitoring.

With continued reference to FIG. 1, data management unit 10 of thecurrently preferred embodiments of the invention includes a data port 44that allows communication between data management unit 10 and a personalcomputer 48 (or other programmable data processor). In the currentlypreferred embodiments of the invention, data port 44 is an RS-232connection that allows serial data communication between data managementunit 10 and personal computer 48. In the practice of the invention,personal computer 48 can be used to supplement data management unit 10by, for example, performing more complex analyses of blood glucose andother data that has been supplied to and stored in the memory circuitsof data management unit 10. With respect to embodiments of the inventionconfigured for use by a child, personal computer 48 can be used by aparent or guardian to review and analyze the child's progress and toproduce printed records for subsequent review by a healthcareprofessional. Alternatively, personal computer 48 can be used to supplydata to data management unit 10 that is not conveniently supplied byusing handheld microprocessor switches 30, 32, 34, 36 and 38 as anoperator interface to the system shown in FIG. 1. For example, someembodiments of the invention may employ a substantial amount ofalphanumeric information that must be entered by the system user.Although it is possible to enter such data by using switches 30, 32, 34,36, and 38 in conjunction with menus and selection screens displayed ondisplay screen 28 of FIG. 1 it may be more advantageous to use a devicesuch as personal computer 48 for entry of such data. However, ifpersonal computer 48 is used in this manner, some trade-off of systemfeatures may be required because data management unit 10 must betemporarily interconnected with personal computer 48 during theseoperations. That is, some loss of system mobility might result because asuitably programmed personal computer would be needed at each locationat which data entry or analysis is to occur.

As is indicated in FIG. 1, data management unit 10 of the currentlypreferred embodiments of the invention also includes a modem that allowsdata communication between data management unit 10 and a remotecomputing facility identified in FIG. 1 as clearinghouse 54 via aconventional telephone line (indicated by reference numeral 50 inFIG. 1) and a modem 52 that interconnects clearinghouse 54 and telephoneline 50. As shall be described in more detail, clearinghouse 54computing facility 54 facilitates communication between a user of thesystem shown in FIG. 1 and his or her healthcare professional and canprovide additional services such as updating system software. As isindicated by facsimile machine 55 of FIG. 1 a primary function ofclearinghouse 54 is providing the healthcare professional withstandardized reports 56, which indicate both the current condition andcondition trends of the system user. Although a single facsimile machine55 is shown in FIG. 1, it will be recognized that numerous healthcareprofessionals (and hence facsimile machine 55) can be connected insignal communication with a clearinghouse 54.

Regardless of whether a compact video game system, another type ofcommercially available handheld microprocessor-based unit, or aspecially designed unit is used, the preferred embodiments of FIG. 1provide a self-care blood glucose monitoring system in which programcartridge (a) handheld microprocessor unit 12 for displayinginstructions for performing the blood glucose test sequence andassociated calibration and test procedures; (b) handheld microprocessorunit 12 for displaying (graphically or alphanumerically) statisticaldata such as blood glucose test results taken during a specific periodof time (e.g., a day, week, etc.); (c) handheld microprocessor unit 12for supplying control signals and signals representative of food intakeor other useful information to data management unit 10; (d) handheldmicroprocessor unit 12 for simultaneous graphical display of bloodglucose levels with information such as food intake; and, (e) handheldmicroprocessor unit 12 for displaying information or instructions from ahealthcare professional that are coupled to data management unit 10 froma clearinghouse 54. The manner in which the arrangement of FIG. 1implements the above-mentioned functions and others can be betterunderstood with reference to FIGS. 2 and 3.

Referring first to FIG. 2, clearinghouse 54 receives data from aplurality of self-care microprocessor-based healthcare systems of thetype shown in FIG. 1, with the individual self-care health monitoringsystems being indicated in FIG. 2 by reference numeral 58. Preferably,the data supplied to clearinghouse 54 by each individual self-carehealth monitoring system 58 consists of “raw data,” i.e., test resultsand related data that was stored in memory circuits of data managementunit 10, without further processing by data management unit 10. Forexample, with respect to the arrangement shown in FIG. 1, blood glucosetest results and associated data such as food intake information,medication dosage and other such conditions are transmitted toclearinghouse 54 and stored with a digitally encoded signal thatidentifies both the source of the information (i.e., the system user orpatient) and those having access to the stored information (i.e., thesystem user's doctor or other healthcare professional).

As shall be recognized upon understanding the manner in which itoperates, clearinghouse 54 can be considered to be a central server forthe various system users (58 in FIG. 2) and each healthcare professional60. In that regard, clearinghouse 54 includes conventionally arrangedand interconnected digital processing equipment (represented in FIG. 2by digital signal processor 57) which receives digitally encodedinformation from a user 58 or healthcare professional processes theinformation as required; stores the information (processed orunprocessed) in memory if necessary; and, transmits the information toan intended recipient (i.e., user 58 or healthcare professional 60).

In FIG. 2 rectangular outline 60 represents one of numerous remotelylocated healthcare professionals who can utilize clearinghouse 54 andthe arrangement described relative to FIG. 1 in monitoring andcontrolling patient healthcare programs. Shown within outline 60 is acomputer 62 (e.g., personal computer), which is coupled to clearinghouse54 by means of a modem (not shown in FIG. 2) and a telephone line 64.Also shown in FIG. 2 is the previously mentioned facsimile machine 55,which is coupled to clearinghouse 54 by means of a second telephone line68. Using the interface unit of computer 62 (e.g., a keyboard orpointing device such as a mouse), the healthcare professional canestablish data communication between computer 62 and clearinghouse 54via telephone line 64. Once data communication is established betweencomputer 62 and clearinghouse 54 patient information can be obtainedfrom clearinghouse 54 in a manner similar to the manner in whichsubscribers to various database services access and obtain information.In particular, the healthcare professional can transmit an authorizationcode to clearinghouse 54 that identifies the healthcare professional asan authorized user of the clearinghouse and, in addition, can transmit asignal representing the patient for which healthcare information isbeing sought. As is the case with conventional database services andother arrangements, the identifying data is keyed into computer 62 bymeans of a conventional keyboard (not shown in FIG. 2) in response toprompts that are generated at clearinghouse 54 for display by thedisplay unit of computer 62 (not shown in FIG. 2).

Depending upon the hardware and software arrangement of clearinghouse 54and selections made by the healthcare professional via computer 62patient information can be provided to the healthcare professional indifferent ways. For example, computer 62 can be operated to access datain the form that it is stored in the memory circuits of clearinghouse 54(i.e., raw data that has not been processed or altered by thecomputational or data processing arrangements of clearinghouse 54). Suchdata can be processed, analyzed, printed and/or displayed by computer 62using commercially available or custom software. On the other hand,various types of analyses may be performed by clearinghouse 54 with theresults of the analyses being transmitted to the remotely locatedhealthcare professional 60. For example, clearinghouse 54 can processand analyze data in a manner identical to the processing and analysisprovided by the self-care monitoring system of FIG. 1. With respect tosuch processing and any other analysis and processing provided byclearinghouse 54 results expressed in alphanumeric format can be sent tocomputer 62 via telephone line 64 and the modem associated with computer62 with conventional techniques being used for displaying and/orprinting the alphanumeric material for subsequent reference.

The arrangement of FIG. 2 also allows the healthcare professional tosend messages and/or instructions to each patient via computer 62telephone line 64 and clearinghouse 54. In particular, clearinghouse 54can be programmed to generate a menu that is displayed by computer 62and allows the healthcare professional to select a mode of operation inwhich information is to be sent to clearinghouse 54 for subsequenttransmission to a user of the system described relative to FIG. 1. Thissame menu (or related submenus) can be used by the healthcareprofessional to select one or more modes of operation of theabove-described type in which either unmodified patient data or theresults of data that has been analyzed by clearinghouse 54 is providedto the healthcare provider via computer 62 and/or facsimile machine 55.

In the currently contemplated arrangements, operation of the arrangementof FIG. 2 to provide the user of the invention with messages orinstructions such as changes in medication or other aspects of thehealthcare program is similar to the operation that allows thehealthcare professional to access data sent by a patient, i.e.,transmitted to clearinghouse 54 by a data management unit 10 of FIG. 1.The process differs in that the healthcare professional enters thedesired message or instruction via the keyboard or other interface unitof computer 62. Once the data is entered and transmitted toclearinghouse 54 it is stored for subsequent transmission to the userfor whom the information or instruction is intended.

With respect to transmitting stored messages or instructions to a userof the invention, at least two techniques are available. The firsttechnique is based upon the manner in which operational modes areselected in the practice of the invention. Specifically, in thecurrently preferred embodiments of the invention, program instructionsthat are stored in data management unit 10 and program cartridge 42cause the system of FIG. 1 to generate menu screens which are displayedby display unit 28 of handheld microprocessor unit 12. The menu screensallow the system user to select the basic mode in which the system ofFIG. 1 is to operate and, in addition, allow the user to selectoperational subcategories within the selected mode of operation. Varioustechniques are known to those skilled in the art for displaying andselecting menu items. For example, in the practice of this invention,one or more main menus can be generated and displayed which allow thesystem user to select operational modes that may include: (a) a monitormode (e.g., monitoring of blood glucose level); (b) a display mode(e.g., displaying previously obtained blood glucose test results orother relevant information); (c) an input mode (e.g., a mode forentering data such as providing information that relates to thehealthcare regimen, medication dosage, food intake, etc.); and, (d) acommunications mode (for establishing a communication link between datamanagement unit 10 and personal computer 48 of FIG. 1 or between datamanagement unit 10 and a remote computing facility such as clearinghouse54 of FIG. 2.

In embodiments of the invention that employ a compact video game systemfor handheld microprocessor unit 12 the selection of menu screens andthe selection of menu screen items preferably is accomplished insubstantially the same manner as menu screens and menu items areselected during the playing of a video game. For example, the programinstructions stored in data management unit 10 and program cartridge 42of the arrangement of FIG. 1 can be established so that a predeterminedone of the compact video game switches (e.g., switch 32 in FIG. 1)allows the system user to select a desired main menu in the event thatmultiple main menus are employed. When the desired main menu isdisplayed, operation by the user of control pad 30 allows a cursor orother indicator that is displayed on the menu to be positioned adjacentto or over the menu item to be selected. Activation of a switch (e.g.,switch 36 of the depicted handheld microprocessor unit causes thehandheld microprocessor unit 12) and/or data management unit 10 toinitiate the selected operational mode or, if selection of operationalsubmodes is required, causes handheld microprocessor unit 12 to displaya submenu.

In view of the above-described manner in which menus and submenus areselected and displayed, it can be recognized that the arrangement ofFIG. 1 can be configured and arranged to display a menu or submenu itemthat allows the user to obtain and display messages or instructions thathave been provided by a healthcare professional and stored inclearinghouse 54. For example, a submenu that is generated uponselection of the previously mentioned communications mode can includesubmenu items that allow the user to select various communication modes,including a mode in which serial data communication is establishedbetween data management unit 10 and clearinghouse 54 and data managementunit 10 transmits a message status request to clearinghouse 54. Whenthis technique is used, the data processing system of clearinghouse 54is programmed to search the clearinghouse memory to determine whether amessage exists for the user making the request. Any messages stored inmemory for that user are then transmitted to the user and processed fordisplay on display unit 28 of handheld microprocessor unit 12. If nomessages exist, clearinghouse 54 transmits a signal that causes displayunit 28 to indicate “no messages.” In this arrangement, clearinghouse 54preferably is programmed to store a signal indicating that a storedmessage has been transmitted to the intended recipient (user). Storingsuch a signal allows the healthcare professional to determine thatmessages sent to clearinghouse 54 for forwarding to a patient have beentransmitted to that patient. In addition, the program instructionsstored in data management unit 10 of FIG. 1 preferably allow the systemuser to designate whether received messages and instructions are to bestored in the memory of data management unit 10 for subsequent retrievalor review. In addition, in some instances it may be desirable to programclearinghouse 54 and data management unit 10 so that the healthcareprofessional can designate (i.e., flag) information such as changes inmedication that will be prominently displayed to the user (e.g.,accompanied by a blinking indicator) and stored in the memory of datamanagement unit 10 regardless of whether the system user designates theinformation for storage.

A second technique that can be used for forwarding messages orinstructions to a user does not require the system user to select a menuitem requesting transmission by clearinghouse 54 of messages that havebeen stored for forwarding to that user. In particular, clearinghouse 54can be programmed to operate in a manner that either automaticallytransmits stored messages for that user when the user operates thesystem of FIG. 1 to send information to the clearinghouse or programmedto operate in a manner that informs the user that messages are availableand allows the user to access the messages when he or she chooses to doso.

Practicing the invention in an environment in which the healthcareprofessional uses a personal computer in some or all of theabove-discussed ways can be very advantageous. On the other hand, theinvention also provides healthcare professionals timely informationabout system users without the need for a computer (62 in FIG. 2) or anyequipment other than a conventional facsimile machine (55 in FIGS. 1 and2) Specifically, information provided to clearinghouse 54 by a systemuser 58 can be sent to a healthcare professional 60 via telephone line68 and facsimile machine 55 with the information being formatted as astandardized graphic or textual report (56 in FIG. 1) Formatting astandardized report 56 (i.e., analyzing and processing data supplied byblood glucose monitor 16 or other system monitor or sensor) can beeffected either by data management unit 10 or within the clearinghousefacility 54. Moreover, various standardized reports can be provided(e.g., the textual and graphic displays discussed below relating toFIGS. 6-10) Preferably, the signal processing arrangement included inclearinghouse 54 allows each healthcare professional 60 to select whichof several standardized reports will be routinely transmitted to thehealthcare professionals' facsimile machine 55 and, to do so on apatient-by-patient (user-by-user) basis.

FIG. 3 illustrates the manner in which data management unit 10 isarranged and interconnected with other system components for effectingthe above-described operational aspects of the invention and additionalaspects that are described relative to FIGS. 4-10. As is symbolicallyindicated in FIG. 3, handheld microprocessor unit 12 and blood glucosemonitor 16 are connected to a dual universal asynchronous receivertransmitter 70 (e.g., by cables 14 and 18 of FIG. 1, respectively). Asalso is indicated in FIG. 3 when a system user connects a personalcomputer 48 (or other programmable digital signal processor) to dataport 44 signal communication is established between personal computer 48and a second dual universal asynchronous receiver transmitter 72 of datamanagement unit 10. Additionally, dual universal asynchronous receivertransmitter 72 is coupled to modem 46 so that data communication can beestablished between data management unit 10 and a remote clearinghouse54 of FIGS. 1 and 2.

Currently preferred embodiments of data management unit 10 include aplurality of signal sensors 74, with an individual signal sensor beingassociated with each device that is (or may be) interconnected with datamanagement unit 10. As previously discussed and as is indicated in FIG.3, these devices include handheld microprocessor unit 12, blood glucosemonitor 16, personal computer 48, remote computing facility 54, and, inaddition, peak-flow meter 20 or other additional monitoring devices 22.Each signal sensor 74 that is included in data management unit 10 iselectrically connected for receiving a signal that will be present whenthe device with which that particular signal sensor is associated isconnected to data management unit 10 and, in addition, is energized(e.g., turned on). For example, in previously mentioned embodiments ofthe invention in which data port 44 is an RS-232 connection, the signalsensor 74 that is associated with personal computer 48 can be connectedto an RS-232 terminal that is supplied power when a personal computer isconnected to data port 44 and the personal computer is turned on. In asimilar manner, the signal sensor 74 that is associated withclearinghouse 54 can be connected to modem 46 so that the signal sensor74 receives an electrical signal when modem 46 is interconnected to aremote computing facility (e.g., clearinghouse 54 of FIG. 2) via atelephone line 50.

In the arrangement of FIG. 3, each signal sensor 74 is a low powerswitch circuit (e.g., a metal-oxide semiconductor field-effecttransistor circuit), which automatically energizes data management unit10 whenever any one (or more) of the devices associated with signalsensors 74 is connected to data management unit 10 and is energized.Thus, as is indicated in FIG. 3 by signal path 76 ach signal sensor is74 interconnected with power supply 78 which supplies operating currentto the circuitry of data management unit 10 and typically consists ofone or more small batteries (e.g., three AAA alkaline cells). Themicroprocessor and other conventional circuitry that enables datamanagement unit 10 to process system signals in accordance with storedprogram instructions is indicated in FIG. 3 by central processing unit(CPU) 80. As is indicated in FIG. 3 by interconnection 82 between CPU 80and battery 78. CPU 80 receives operating current from power supply 78with power being provided only when one or more of the signal sensors 74are activated in the previously described manner. A clock/calendarcircuit 84 is connected to CPU (80 via signal path 86 in FIG. 3) toallow time and date tagging of blood glucose tests and otherinformation. Although not specifically shown in FIG. 3, operating poweris supplied to clock/calendar 84 at all times.

In operation, CPU 80 receives and sends signals via a data bus(indicated by signal path 88 in FIG. 3) which interconnects CPU 80 withdual universal asynchronous receiver transmitters 70 and 72. The databus 88 also interconnects CPU 80 with memory circuits which, in thedepicted embodiment, include a system read-only memory (ROM) 90 aprogram random access memory (RAM) 92 and an electronically erasableread-only memory (EEROM) 94. System ROM 90 stores program instructionsand any data required in order to program data management unit 10 sothat data management unit 10 and a handheld microprocessor unit 12 thatis programmed with a suitable program cartridge 42 provide thepreviously discussed system operation and, in addition, system operationof the type described relative to FIGS. 4-10. During operation of thesystem, program RAM 92 provides memory space that allows CPU 80 to carryout various operations that are required for sequencing and controllingthe operation of the system of FIG. 1. In addition, RAM 92 can providememory space that allows external programs (e.g., programs provided byclearinghouse 54 to be stored and executed. EEROM 94 allows bloodglucose test results and other data information to be stored andpreserved until the information is no longer needed (i.e., untilpurposely erased by operating the system to provide an appropriate erasesignal to EEROM 94).

FIGS. 4-10 illustrate typical screen displays that are generated by thearrangement of the invention described relative to FIGS. 1-3. Referencewill first be made to FIGS. 4 and 5 which exemplify screen displays thatare associated with operation of the invention in the blood glucosemonitoring mode. Specifically, in the currently preferred embodiments ofthe invention, blood glucose monitor 16 operates in conjunction withdata management unit 10 and handheld microprocessor unit 12 to: (a) atest or calibration sequence in which tests are performed to confirmthat the system is operating properly; and, (b) the blood glucose testsequence in which blood glucose meter 16 senses the user's blood glucoselevel. Suitable calibration procedures for blood glucose monitors areknown in the art. For example, blood glucose monitors often are suppliedwith a “code strip,” that is inserted in the monitor and results in apredetermined value being displayed and stored in memory at theconclusion of the code strip calibration procedure. When such a codestrip calibration procedure is used in the practice of the invention,the procedure is selected from one of the system menus. For example, ifthe system main menu includes a “monitor” menu item, a submenudisplaying system calibration options and an option for initiating theblood glucose test may be displayed when the monitor menu item isselected. When a code strip option is available and selected, a sequenceof instructions is generated and displayed by display screen 28 ofhandheld microprocessor unit 12 to prompt the user to insert the codestrip and perform all other required operations. At the conclusion ofthe code strip calibration sequence, display unit 28 of handheldmicroprocessor unit 12 displays a message indicating whether or not thecalibration procedure has been successfully completed. For example, FIG.4 illustrates a screen display that informs the system user that thecalibration procedure was not successful and that the code strip shouldbe inserted again (i.e., the calibration procedure is to be repeated).As is indicated in FIG. 4, display screens that indicate a potentialmalfunction of the system include a prominent message such as the“Attention” notation included in the screen display of FIG. 4.

As previously indicated, the blood glucose test sequence that isemployed in the currently preferred embodiment of the invention is ofthe type in which a test strip is inserted in a receptacle that isformed in the blood glucose monitor. A drop of the user's blood is thenapplied to the test strip and a blood glucose sensing sequence isinitiated. When the blood glucose sensing sequence is complete, theuser's blood glucose level is displayed.

In the practice of the invention, program instructions stored in datamanagement unit 10 (e.g., system ROM 90 of FIG. 3) and programinstructions stored in program cartridge 42 of handheld microprocessorunit 12 cause the system to display step-by-step monitoring instructionsto the system user and, in addition, preferably result in display ofdiagnostic messages if the test sequence does not proceed in a normalfashion. Although currently available self-containedmicroprocessor-based blood glucose monitors also display testinstruction and diagnostic messages, the invention provides greatermessage capacity and allows multi-line instructions and diagnosticmessages that are displayed in easily understood language rather thancryptic error codes and abbreviated phraseology that is displayed oneline or less at a time. For example, as is shown in FIG. 5 the completeresults of a blood glucose test (date, time of day, and blood glucoselevel in milligrams per deciliter) can be concurrently displayed bydisplay screen 28 of handheld microprocessor unit 12 along with aninstruction to remove the test strip from blood glucose monitor 16. Aspreviously mentioned, when the blood glucose test is complete, the timeand date tagged blood glucose test result is stored in the memorycircuits of data management unit 10 (e.g., stored in EEPROM 94 of FIG.3)

The arrangement shown and described relative to FIGS. 1-3 also isadvantageous in that data relating to food intake, concurrent medicationdosage and other conditions easily can be entered into the system andstored with the time and date tagged blood glucose test result for laterreview and analysis by the user and/or his or her healthcareprofessional. Specifically, a menu generated by the system at thebeginning or end of the blood glucose monitoring sequence can includeitems such as “hypoglycemic” and “hyperglycemic,” which can be selectedusing the switches of handheld microprocessor unit 12 (e.g., operationof control pad 30 and switch 36 in FIG. 1) to indicate the user wasexperiencing hypoglycemic or hyperglycemic symptoms at the time ofmonitoring blood glucose level. Food intake can be quantitativelyentered in terms of “Bread Exchange” units or other suitable terms by,for example, selecting a food intake menu item and using a submenudisplay and the switches of handheld microprocessors 2 to select andenter the appropriate information. A similar menu item—submenu selectionprocess also can be used to enter medication data such as the type ofinsulin used at the time of the glucose monitoring sequence and thedosage.

As was previously mentioned, program instructions stored in datamanagement unit 10 and program instructions stored in program cartridge42 of handheld microprocessor unit 12 enable the system to displaystatistical and trend information either in a graphic or alphanumericformat. As is the case relative to controlling other operational aspectsof the system, menu screens are provided that allow the system user toselect the information that is to be displayed. For example, in thepreviously discussed embodiments in which a system menu includes a“display” menu item, selection of the menu item results in the displayof one or more submenus that list available display options. Forexample, in the currently preferred embodiments, the user can selectgraphic display of blood glucose test results over a specific period oftime, such as one day, or a particular week. Such selection results indisplays of the type shown in FIGS. 6 and 7 respectively. When bloodglucose test results for a single day are displayed (FIG. 6) the day ofthe week and date can be displayed along with a graphic representationof changes in blood glucose level between the times at which testresults were obtained. In the display of FIG. 6, small icons identifypoints on the graphic representation that correspond to the bloodglucose test results (actual samples). Although not shown in FIG. 6,coordinate values for blood glucose level and time of day can bedisplayed if desired. When the user chooses to display a weekly trendgraph (FIG. 7) the display generated by the system is similar to thedisplay of a daily graph, having the time period displayed inconjunction with a graph that consists of lines interconnecting pointsthat correspond to the blood glucose test results.

The screen display shown in FIG. 8 is representative of statistical datathat can be determined by the system of FIG. 1 (using conventionalcomputation techniques) and displayed in alphanumeric format. Aspreviously mentioned, such statistical data and information in variousother textual and graphic formats can be provided to a healthcareprofessional (60 in FIG. 2) in the form of a standardized report 56(FIG. 1) that is sent by clearinghouse 54 to facsimile machine 55. Inthe exemplary screen display of FIG. 8, statistical data for bloodglucose levels over a period of time (e.g., one week) or, alternatively,for a specified number of monitoring tests is provided. In the exemplarydisplay of FIG. 8 the system (data management unit 10 or clearinghouse54) also calculates and displays (or prints) the average blood glucoselevel and the standard deviation. Displayed also is the number of bloodglucose test results that were analyzed to obtain the average and thestandard deviation; the number of test results under a predeterminedlevel (50 milligrams per deciliter in FIG. 8) and the number of bloodglucose tests that were conducted while the user was experiencinghypoglycemic symptoms. As previously noted, in the preferred embodimentsof the invention, a screen display that is generated during the bloodglucose monitoring sequence allows the user to identify the blood samplebeing tested as one taken while experiencing hyperglycemic orhypoglycemic symptoms and, in addition, allows the user to specify otherrelevant information such as food intake and medication information.

The currently preferred embodiments of the invention also allow the userto select a display menu item that enables the user to sequentiallyaddress, in chronological order, the record of each blood glucose test.As is indicated in FIG. 9, each record presented to the system userincludes the date and time at which the test was conducted, the bloodglucose level, and any other information that the user provided. Forexample, the screen display of FIG. 9 indicates that the user employedhandheld microprocessor unit 12 as an interface to enter data indicatinguse of 12.5 units of regular insulin; 13.2 units of “NPH” insulin; foodintake of one bread exchange unit; and pre-meal hypoglycemic symptoms.

Use of data management unit 10 in conjunction with handheldmicroprocessor unit 12 also allows display (or subsequent generation ofa standardized report showing blood glucose test results along with foodintake and/or medication information. For example, shown in FIG. 10 is adaily graph in which blood glucose level is displayed in the mannerdescribed relative to FIG. 6. Related food intake and medication dosageis indicated directly below contemporaneous blood glucose levels byvertical bar graphs.

It will be recognized by those skilled in the art that theabove-described screen displays and system operation can readily beattained with conventional programming techniques of the type typicallyused in programming microprocessor arrangements. It also will berecognized by those skilled in the art that various other types ofscreen displays can be generated and, in addition, that numerous otherchanges can be made in the embodiments described herein withoutdeparting from the scope and the spirit of the invention.

It will also be recognized by those skilled in the art that theinvention can be embodied in forms other than the embodiments describedrelative to FIGS. 1-10. For example, the invention can employ compactvideo game systems that are configured differently than the previouslydiscussed handheld video game systems and palm-top computers. Morespecifically, as is shown in FIG. 11 a self-care health monitoringsystem arranged in accordance with the invention can employ a compactvideo game system of the type that includes one or more controllers 100that are interconnected to a game console 102 via cable 104. As isindicated in FIG. 11, game console 102 is connected to a video monitoror television 106 by means of a cable 108. Although differing inphysical configuration, controller 100, game console 102 and thetelevision or video monitor 106 collectively function in the same manneras the handheld microprocessor 12 of FIG. 1. In that regard, a programcartridge 42 is inserted into a receptacle contained in game console 102with program cartridge 42 including stored program instructions forcontrolling microprocessor circuitry that is located inside game console102. Controller 100 includes a control pad or other device functionallyequivalent to control pad 30 of FIG. 1 and switches that functionallycorrespond to switches 32-38 of FIG. 1.

Regardless of whether the invention is embodied with a handheldmicroprocessor unit (FIG. 1) or an arrangement such as the compact videogame system (FIG. 11) in some cases it is both possible and advantageousto apportion the signal processing functions and operations differentlythan was described relative to FIGS. 1-10. For example, in somesituations, the microprocessor-based unit that is programmed by a cardor cartridge (e.g., handheld unit 12 of FIG. 1 or compact video gameconsole 102 of FIG. 1) includes memory and signal processing capabilitythat allows the microprocessor to perform all or most of the functionsand operations attributed to data management unit 10 of the embodimentsdiscussed relative to FIGS. 1-10. That is, the digitally encoded signalsupplied by blood glucose monitor 16 (or one of the other monitors 20and 22 of FIG. 1) can be directly coupled to the microprocessor includedin game console 102 of FIG. 11 or handheld microprocessor 12 of FIG. 1.In such an arrangement, the data management unit is a relatively simplesignal interface (e.g., interface unit 110 of FIG. 11) the primarypurpose of which is carrying signals between the blood glucose monitor16 (or other monitor) and the microprocessor of game console 102 (FIG.11) or handheld unit (FIG. 1). In some situations, the interface unitmay consist primarily or entirely of a conventional cable arrangementsuch as a cable for interconnection between RS232 data ports or otherconventional connection arrangements. On the other hand, as is shown inFIG. 11, signal interface 110 can either internally include or beconnected to a modem 52, which receives and transmits signals via atelephone line 50 in the manner described relative to FIGS. 1 and 2.

It also should be noted that all or a portion of the functions andoperations attributed to data management unit 10 of FIG. 1 can beperformed by microprocessor circuitry located in blood glucose monitor16 (or other monitor that is used with the system). For example, anumber of commercially available blood glucose monitors include aclock/calendar circuit of the type described relative to FIG. 3 and, inaddition, include microprocessor circuitry for generating visual displaysignals and signals representative of both current and past values ofmonitored blood glucose level. Conventional programming and designtechniques can be employed to adapt such commercially available unitsfor the performance of the various functions and operations attributedin the above discussion of FIGS. 1-11 to data management unit 10 and/orthe microprocessors of handheld unit and compact video console 102. Inarrangements in which the blood glucose monitor (or other systemmonitor) includes a microprocessor that is programmed to provide signalprocessing in the above-described manner, the invention can use a signalinterface unit 110 of the above type. That is, depending upon the amountof signal processing effected by the monitoring unit (e.g., bloodglucose monitor 16) and the amount of signal processing performed by themicroprocessor of video game console 102 (or handheld unit the signalinterface required ranges from a conventional cable (e.g.,interconnection of RS232 ports) to an arrangement in which signalinterface 110 is arranged for signal communication with an internal orexternal modem (e.g., modem 52 of FIG. 11) or an arrangement in whichsignal interface provides only a portion of the signal processingdescribed relative to FIGS. 1-10.

The invention also is capable of transmitting information to a remotelocation (e.g., clearinghouse 54 and/or a remotely located healthcareprofessional) by means other than conventional telephone lines. Forexample, a modem (52 in FIGS. 1 and 11) that is configured for use witha cellular telephone system can be employed to transmit the signalsprovided by the healthcare monitoring system to a remote location viamodulated RF transmission. Moreover, the invention can be employed withvarious digital networks such as recently developed interactive voice,video and data systems such as television systems in which a televisionand user interface apparatus is interactively coupled to a remotelocation via coaxial or fiber optic cable and other transmission media(indicated in FIG. 11 by cable 112 which is connected to television orvideo monitor 106). In such an arrangement, compact video gamecontroller 100 and the microprocessor of video game console 102 can beprogrammed to provide the user interface functions required fortransmission and reception of signals via the interactive system.Alternatively, the signals provided by video game console 102 (orhandheld unit 12 if FIG. 1) can be supplied to the user interface of theinteractive system (not shown in FIG. 11) in a format that is compatiblewith the interactive system and allows the system user interface to beused to control signal transmission between the healthcare system and aremote facility such as clearinghouse 54, FIGS. 1 and 2.

1. An airflow monitoring system comprising: (a) at least one centralserver arranged to receive and communicate data; (b) at least onemicroprocessor-based subsystem (i) including at least onemicroprocessor, display and memory and (ii) configured to presentinformation on the display and provide a digital signal representativeof airflow form a person and (iii) arranged to facilitate communicationof airflow-related data to the central server; and (c) at least onehealth care professional computer in signal communication with thecentral server to receive health-related information based on theairflow-related data received from the microprocessor-based subsystem.2. The system of claim 1, wherein the digital signal is representativeof airflow that results when a person expels a breath of air.
 3. Thesystem on claim 2, configured to realize systems for at least one of (a)self-care monitoring and (b) control of afflictions.
 4. The system ofclaim 3, wherein the affliction is a chronic respiratory affliction. 5.The system of claim 4, wherein the microprocessor-based subsystemfurther includes (a) a data management unit; and (b) a monitoring devicethat can be received directly by the data management unit or that can beconnected to data management unit.
 6. The system of claim 5, wherein atleast one monitoring device is (a) configured to monitor at least oneperson's condition; and (b) connected to facilitate communication ofdata related to the monitored condition to the central server.
 7. Thesystem of claim 6, wherein at least one monitoring device includes oneor more of the set consisting of (a) a blood glucose monitor; (b) ablood pressure monitor; (c) a pulse monitor; and (d) a body temperaturemonitor.
 8. The system of claim 2, wherein at least one microprocessor,display and memory is in a handheld device.
 9. The system of claim 2,wherein the microprocessor-based subsystem is capable of displayingpictorial information.
 10. The system of claim 2, wherein themicroprocessor-based subsystem is capable of displaying animatedinformation.
 11. The system of claim 3, the microprocessor-basedsubsystem further includes at least one of an insertable program card ofcartridge.
 12. The system of claim 11, wherein instructions in theprogram card or cartridge are configured to facilitate the monitoring.13. The system of claim 2, further including at least one personalcomputer connected for use by the person.
 14. The system of claim 2,wherein the system is configured to use the airflow-related data toprocess a report.
 15. The system of claim 14, wherein the reportincludes graphs and/or icons.
 16. The system of claim 14, wherein thereport includes information for a period of time.
 17. The system ofclaim 12 wherein the information presented includes at least onemessage.
 18. The system of claim 17, wherein the message is transmittedto a specific person.
 19. The system of claim 2, wherein the informationpresented includes step-by-step instructions.
 20. The system of claim 2,wherein the information presented is educational or motivational. 21.The system of claim 2, wherein the presentation of information can becontrolled using at least one menu.
 22. The system of claim 2, whereinthe system is configured to enable at least one program to be providedfor storage in a memory and execution by the micro-processor-basedsubsystem.
 23. The system of claim 22, further comprising at least oneof an insertable program card or cartridge and wherein at least part ofthe program is stored on the card or cartridge. 24-82. (canceled)